Gabrielle Hirneise

MedCrypt cybersecurity experts Axel Wirth and Vidya Murthy explain how healthcare systems and medical device companies alike can account for known cybersecurity vulnerabilities, as shared by manufacturers, to minimize the risk of a cyber attack.

Brian Stallard

Ask anyone in healthcare technology management (HTM) what worries them most about the future of medical devices and they’ll likely say the same thing: cybersecurity.

Brian Stallard

Thought leaders and subject-matter experts from AAMI and its robust HTM community have crafted two valuable resources that can be immediately put to use by ambitious and professional HTM departments looking to increase their compliance and recognition.

Chris Hayhurst

Two trainees at ReNew Biomedical Services have become the first participants in AAMI’s BMET Apprenticeship Program to earn their CABT certifications, showcasing the effectiveness of this new pipeline for BMET training.

Randolph Fillmore

FDA has notified patients, healthcare providers, and manufacturers of cybersecurity vulnerabilities that could affect certain medical devices.

Jennifer Peters

Mayo Clinic HTM head Keith Whitby describes how to better manage the unique corner of the healthcare Internet of Things that is medical devices through processes such as micro-segmentation.

Gabrielle Hirneise

In light of developments spurred by the COVID-19 pandemic, cybersecurity and HTM experts shared their future plans for implementing partially-remote healthcare systems during a HIMSS21 panel.

Brian Stallard

AAMI will be offering a new training course: “Medical Cybersecurity 101 for HTM Professionals.” The Sep 21-23 course will provide the knowledge and skills to effectively plan for, implement, and manage a medical device security program.

Martha Vockley

The FDA is making more regulatory science tools publicly available to help early-stage innovators demonstrate the safety and effectiveness of their healthcare technology.

Gavin Stern

The Food and Drug Administration (FDA) has announced increases for its medical device user fees for fiscal year 2022, which go into effect on October 1. The average increase in fees is 2.5%, which is lower than than increases in recent years of 7% (2021) and 6% (2020).

Fran Kritz

More than 400 healthcare organizations have sent a letter to the U.S. Congress warning of a “telehealth cliff” once the COVID-19 public health emergency—and temporary regulatory changes—eventually end.

Fran Kritz

A recent study published in the British Medical Journal (BMJ) found that many mobile health apps (mHealth apps) include code that could potentially collect user data. For the study, researchers from Macquarie University in Sydney looked at close to 16,000 free mHealth apps and compared to close to 9,000 non-health apps.

Martha Vockley

With cybersecurity threats on the rise in healthcare, it’s vital for product developers to identify risks and mitigate any vulnerabilities to healthcare technology. But what’s the best way to go about this?

Martha Vockley

Martha Vockley

Are there opportunities you’re missing because you have neither the time nor the available talent to pursue them? Are you confident you can consistently recruit new talent and retain the talent you have? How prepared are you if someone were to leave your organization?

Fran Kritz

A device designed specifically for neonates and infants, Medtronic’s SonarMed airway monitoring system, recently launched in the United States and checks for unplanned extubations, which can result in insufficient oxygen to the brain within just a few seconds.

Fran Kritz

Janet Woodcock, MD, acting commissioner of the FDA, recently asked Congress for additional powers and funding to help prevent medical device shortages. In a blog post, Woodcock said that the COVID-19 pandemic had “exposed great weaknesses in the medical device supply chain" that the U.S. needs to resolve to ensure it is better prepared for future crises.

Steven D. Baker

Until healthcare delivery organizations begin standing their ground and demanding that medical device manufacturers address vulnerabilities before purchasing equipment, security shortcomings will continue to proliferate, warns CYBER INSIGHTS guest author Steven D. Baker, PhD, AAMIF.

Martha Vockley

The U.S. FDA is contributing to a new public-private initiative to create a strategic framework aimed at transforming the pediatric medical device ecosystem. The agency is also expanding efforts to collect crucial, real-world data.

Fran Kritz

Citing sufficient U.S. supply, the FDA recently revoked emergency use authorizations (EUAs) for disposable respirators not approved by National Institute of Occupational Safety and Health (NIOSH), as well as some decontamination equipment.